Non-Human ResearchNon-Human Researchresearch that does not involve "human subjects" as defined by the regulations. does not require IRB approval. However, we strongly encourage you to submit a brief description using our short form so that we can make an official determination. You may find this useful if you plan on submitting your research to a journal or professional meeting.
Non-human research does not involve:
- Obtaining information or biospecimens through interventionInterventionall physical procedures by which information or biospecimens are gathered or manipulation of the subject or the subject's environment performed for research purposes. or interactionInteractionany communication or interpersonal contact between investigator and subject. with one or more living individuals, and using, studying, or analyzing the information or biospecimens; or
- Obtaining, using, studying, analyzing, or generating identifiable private informationIdentifiable Private Informationprivate information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. or identifiable biospecimens; or
- Including human subjects as recipients of an FDAFDAabbreviation for US Food and Drug Administration. -regulated test articleTest Articlea general term that encompasses Drug, Device, food additives, etc. that are regulated by the FDA. (such as an unapproved drugDrug1) a substance recognized by an official pharmacopoeia or formulary; AND 2) a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; AND 3) a substance (other than food) intended to affect the structure or any function of the body; AND 4) a substance intended for use as a component of a medicine but not a Device or a component, part or accessory of a device. Note: biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process). or deviceDevicean instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1) recognized in the USPÐNF, OR 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. ) or as controls.
Examples of Non-Human Research include:
- Only using leftover, de-
identifiedIdentifiedindividual is identified as a prospective subject during recruitment: 1) by obtaining the results of procedures performed as part of the practice of medicine, 2) by responding to recruitment activities, or 3) referred by a provider.
- Only using commercial cell lines
- Data/specimens from a repositoryRepositorydata management centers (data centers) and human specimen repositories (sometimes called registries, banks, or libraries) are used to store data and/or specimens for future use. When the use is for research purposes, the data centers/repositories must be approved by the Institutional Review Board (IRB). Human Specimen Repositories collect, store, and distribute human tissue/specimen materials for research purposes. Repository activities involve three components: (i) the collectors of tissue samples; (ii) the repository storage and data management center; and (iii) the recipient investigators. Human repository repositories may be combined with data management centers. received in a de-identified manner by recipient investigator
- Use of publicly available data/specimensPublicly Available Data/SpecimensData and/or biospecimens that are accessible to anyone in the general public, without the need for special qualifications, permissions, or privileges. Examples include: data/biospecimens available for public purchase, searchable online, or available at a library
- Only using commercial cell lines
Submit the form to IRBmail@uthscsa.edu for an IRB determination of non-human subjects research: